Impact of statins on risk of new onset diabetes mellitus: a population-based cohort study using the Korean National Health Insurance claims database

Abstract

Statin therapy is beneficial in reducing cardiovascular events and mortalities in patients with atherosclerotic cardiovascular diseases. Yet, there have been concerns of increased risk of diabetes with statin use. This study was aimed to evaluate the association between statins and new onset diabetes mellitus (NODM) in patients with ischemic heart disease (IHD) utilizing the Korean Health Insurance Review and Assessment Service claims database. Among adult patients with preexisting IHD, new statin users and matched nonstatin users were identified on a 1:1 ratio using proportionate stratified random sampling by sex and age. They were subsequently propensity score matched further with age and comorbidities to reduce the selection bias. Overall incidence rates, cumulative rates and hazard ratios (HRs) between statin use and occurrence of NODM were estimated. The subgroup analyses were performed according to sex, age groups, and the individual agents and intensities of statins. A total of 156,360 patients (94,370 in the statin users and 61,990 in the nonstatin users) were included in the analysis. The incidence rates of NODM were 7.8% and 4.8% in the statin users and nonstatin users, respectively. The risk of NODM was higher among statin users (crude HR 2.01, 95% confidence interval [CI] 1.93-2.10; adjusted HR 1.84, 95% CI 1.63-2.09). Pravastatin had the lowest risk (adjusted HR 1.54, 95% CI 1.32-1.81) while those who were exposed to more than one statin were at the highest risk of NODM (adjusted HR 2.17, 95% CI 1.93-2.37). It has been concluded that all statins are associated with the risk of NODM in patients with IHD, and it is believed that our study would contribute to a better understanding of statin and NODM association by analyzing statin use in the real-world setting. Periodic screening and monitoring for diabetes are warranted during prolonged statin therapy in patients with IHD.

Keywords: Atorvastatin; Fluvastatin; IHD; Ischemic heart disease; Lovastatin; NODM; Pitavastatin; Pravastatin; Rosuvastatin; Simvastatin; new onset diabetes mellitus.

Figure 1

Flow chart of the study population and schematic description of the study design. Notes: (A) Flowchart of the study population. (B) Schematic description of the study design.

Figure 2

Cumulative incidence of NODM between statin users and nonstatin users during the follow-up period. Notes: (A) Statin users versus nonstatin users. (B) Statin users versus nonstatin users, divided by sex. (C) Statin users versus nonstatin users, divided by age groups. Abbreviation: NODM, new onset diabetes mellitus.